ENCOR® FSENCOR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741086557), received between Mar 2, 2018 and May 22, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN (B)(6) AND ENCOR FOOT PEDAL SN (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251665 ↗
• InjuryMay 22, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN (B)(6) AND ENCOR FOOT PEDAL SN (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251659 ↗
• MalfunctionJan 21, 2026Application Program Problem

  A 66 YEAR OLD FEMALE PATIENT UNDERWENT A STEREOTACTIC BREAST BIOPSY PROCEDURE USING THE ENCOR ENSPIRE SYSTEM. DURING THE PROCEDURE, ENCOR ENSPIRE SYSTEM UNEXPECTEDLY ENTERED INTO REBOOT MODE WHILE THE NEEDLE WAS INSIDE THE PATIENT'S BREAST. THE PROCEDURE WAS PERFORMED IN AN UPRIGHT POSITION USING VERTICAL APPROACH AT THE CC ANGLE. NO BUTTONS WERE PRESSED ON THE ENCOR FOOT PEDAL OR THE ENCOR DRIVER. WHILE THE NEEDLE WAS IN THE PATIENT'S BREAST AND THE RADIOLOGIST WAS PREPARING TO ADMINISTER ADDITIONAL LIDOCAINE, THE TECHNOLOGIST BELIEVES THE RADIOLOGIST MOVED THE CABLES OUT OF THE WAY BY THE NEEDLE. THEN, THE ENCOR ENSPIRE SYSTEM'S SCREEN SWITCHED TO A REBOOT MODE. SO, THE TECHNOLOGIST POWERED OFF THE ENCOR ENSPIRE SYSTEM AND INSTRUCTED THE RADIOLOGIST TO REMOVE THE LIDOCAINE SYRINGE AND WITHDRAW THE NEEDLE. FURTHERMORE, THE TECHNICIAN HAD POWERED THE ENCOR ENSPIRE SYSTEM BACK ON AND HAD TO REATTACH THE NEEDLE AND RECALIBRATE. THEN, THE TECHNICIAN ATTACHED THE NEEDLE AND THE RADIOLOGIST ADVANCED THE NEEDLE BACK INTO THE PATIENT'S BREAST TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141739 ↗
• MalfunctionJan 5, 2026Unintended Movement

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S. IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954547 ↗
• MalfunctionDec 17, 2025Application Program Problem; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE-ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE.IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN (B)(6), (WORK ORDER-(B)(4)), ENCOR DRIVER SN UNK (WORK ORDER-(B)(4)) AND ENCOR FOOT PEDAL SN UNK, (WORK ORDER-(B)(4)) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825498 ↗
• MalfunctionDec 17, 2025Application Program Problem; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN (B)(6), ENCOR DRIVER SN (B)(6) AND ENCOR FOOT PEDAL SN UNK (WO-00121347) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825495 ↗
• MalfunctionOct 16, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN UPRIGHT VERTICAL STEREOTACTIC PROCEDURE, THE ENCOR DRIVER WOULD NOT STOP SAMPLING AFTER THE USER REMOVED THEIR FOOT OFF THE ENCOR FOOT PEDAL. THE ENCOR ENSPIRE NEEDED TO BE SWITCHED OFF TO STOP THE DRIVER FROM SAMPLING. AFTER THE ENSPIRE WAS SWITCHED BACK ON, ERROR CODE 1005 (DRIVER BUTTON OR CONTACT STUCK DURING INITIALIZATION) WAS DISPLAYED. THE ENSPIRE WAS SWITCHED OFF BEFORE REMOVING THE NEEDLE FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY. IT WAS IDENTIFIED THAT THE ENCOR ENSPIRE, THE ENCOR FOOT PEDAL AND THE ENCOR DRIVER WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307801 ↗
• MalfunctionSep 4, 2025Application Program Problem; Application Program Problem

  A PATIENT UNDERWENT A STEREOTACTIC BIOPSY PROCEDURE USING ENCOR ENSPIRE SYSTEM AT VERTICAL APPROACH. DURING THE PROCURE, IT WAS REPORTED THAT THE ENCOR ENSPIRE SYSTEM RETURNED TO THE DRIVER READY SCREEN DURING SAMPLING AFTER CALIBRATION WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS STILL INSIDE THE PATIENT. IMMEDIATELY BEFORE THE SCREEN CHANGED, THE FOOT PEDAL WAS BEING HELD DOWN. REPORTEDLY, THE ENCOR DRIVER HAD SUCCESSFULLY COMPLETED CALIBRATION PRIOR TO THE ISSUE. HOWEVER, THE SCREEN REVERTED TO THE DRIVER READY SCREEN BEFORE PROMPTING THE USER TO RECALIBRATE THE NEEDLE. THE PROCEDURE WAS COMPLETED BY REPLACING THE UNIT WITH ANOTHER ENCOR ENSPIRE SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960999 ↗
• MalfunctionJul 23, 2025Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A STEREOTACTIC MAMMOGRAPHY BREAST BIOPSY PROCEDURE USING ENCOR DRIVER BY VERTICAL APPROACH. IT WAS REPORTED THAT THE DEVICE CONTINUED TO OPERATE WITHOUT ANY BUTTON BEING PRESSED. FURTHER CLARIFICATION WAS PROVIDED THAT DURING THE SAMPLING PROCESS, THE SAMPLE BUTTON ON EITHER THE ENCOR DRIVER OR THE ENCOR FOOT PEDAL FAILED TO RESPOND. THE ENCOR ENSPIRE SYSTEM WAS ULTIMATELY STOPPED THROUGH MANUAL INTERVENTION. THERE WAS NO PATIENT INJURY. DURING THE MIDDLE OF THE SAMPLING PROCESS, THE ENCOR DRIVER CONTINUED TO TAKE SAMPLES WITHOUT ANY USER INPUT AND DID NOT STOP SAMPLING, EVEN WITHOUT THE SAMPLE BUTTON BEING PRESSED. THE USER WAS UNABLE TO STOP THE ENCOR DRIVER THEREFORE, THE USER HAD TO COMPLETELY STOP THE ENCOR ENSPIRE SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574159 ↗
• MalfunctionFeb 19, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DRIVER DID NOT CALIBRATE AND RETURNED TO THE START SCREEN WITHOUT ANY COMMAND. IT WAS FURTHER REPORTED THAT THE PEDAL CALIBRATED SUCCESSFULLY BUT ASKED US TO REMOVE THE DRIVER AFTER COLLECTING THE TWO TO THREE FRAGMENTS, FURTHERMORE, THE DRIVER CALIBRATES CORRECTLY, HOWEVER THE SYSTEM RETURNS TO THE HOME SCREEN WITHOUT ANY COMMANDS. REPORTEDLY, THE COMMUNICATION ISSUE HAS BEEN OCCURRED BETWEEN THE DRIVER OR FOOT PEDAL AND THE SOURCE OF COMMUNICATION FAILURE COULD NOT BE IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407706 ↗
• MalfunctionJan 29, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN ATTACHING THE ENCOR PROBE TO THE FIRE FORWARD AND ATTACHING THE FIRE FORWARD TO THE MAMMO UNIT THE SAMPLE STARTED WITHOUT THE HCP SELECTING THE SAMPLING BUTTON NOR STEPPING ON THE FOOT PEDAL. WE COULD NOT ENTER THE PATIENT AS THE MACHINE KEPT ON WANTING TO RESTORE VACUUM AND JUST KEPT ON SAMPLING UNTIL WE REMOVED THE PROBE FROM THE FIREFORWARD OR WHEN REMOVING THE PROBE AND THE FIREFORWARD TOGETHER FROM THE MAMMO UNIT. WE TRIED 2 ENCOR PROBES TO UNDERSTAND IF THIS IS A PROBE ERROR OR A ENCOR UNIT DRIVER ERROR. IT SEEMS TO BE ENCOR UNIT DRIVER ERROR AND NOT PROBE ERROR. THE TWO PROBES USED HAS THE SAME LOT NUMBER. THE INCIDENT OCCURRED BEFORE USE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261469 ↗
• MalfunctionDec 27, 2024Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED EXCISION PROCEDURE, WHEN THE NEEDLE WAS PLACED IN THE BREAST, IT STARTED TO TAKE THE FIRST SAMPLE WHICH GAVE ALLEGEDLY AN ERROR REGARDING NEEDLE CUTTER NOT OPENING CORRECTLY, SO USER TOOK THE NEEDLE OUT THE PATIENT AND DETACHED AND CALIBRATED AGAIN, THEN WENT TO REPOSITION THE NEEDLE IN THE BREAST, THEN THE USER SAW THE NEEDLE ALLEGEDLY SPUN AROUND IN THE BREAST REALLY FAST LIKE A DRILL, FOLLOWED BY A FEW SPARKS WERE NOTICED. IT WAS FURTHER REPORTED THAT THE USER CANNOT RECALL THE SYSTEM ERROR CODE THAT DISPLAYED ON THE MONITOR'S SCREEN. FURTHERMORE, THE FOOT WAS ON PEDAL WHEN THE DRIVER STARTED DRILLING MOTION AND THEY LET GO OF THE PEDAL AND THE DRIVER CONTINUED TO DRILL AND THEN HAD TO REMOVE THE DRIVER/NEEDLE FROM THE PATIENT WHILE IT WAS STILL DRILLING. IN ADDITION, AT THAT POINT THE NEEDLE WAS REMOVED FROM THE BREAST AND REPLACED THE NEEDLE AND THE ENCORE MACHINE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024980 ↗
• MalfunctionNov 4, 2024Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A PATTERN WAS SELECTED, HOWEVER THE UNIT IGNORED DESIRED PATTERN AND SAMPLED A FULL CLOCK ROTATION, AND THEN DEVICE STOPPED RESPONDING. IT WAS FURTHER REPORTED THAT THE TOUCHSCREEN, DRIVER AND PEDAL WERE ALL ALLEGEDLY STOPPED RESPONDING. IT HAS BEEN TURNED OFF AND BACK ON, DRIVER AND PEDAL DETACHED AND REATTACHED AND NEW NEEDLE LOADED AND STILL IT DOES NOT RESPOND. FURTHERMORE, WE HAD SET THE MACHINE TO AVOID THE 7:00 AND 9:00 POSITIONS. ALTHOUGH THE SCREEN SHOWED THOSE POSITIONS GRAYED OUT, THE NEEDLE DID NOT AVOID THESE AREAS WHEN SAMPLING. IT IGNORED THE PATTERN AND TOOK A FULL CLOCK SAMPLE INSTEAD. AFTER THE SAMPLES WERE TAKEN, THE NEEDLE BEGAN PULSE AS IF IT WAS STUCK AND THE UNIT STOPPED RESPONDING. WE USED THE FOOT PEDAL TO INITIATE SAMPLING. AFTER SAMPLES WERE TAKEN AND THE UNIT BECAME STUCK AND STOPPED RESPONDING, WE ATTEMPTED TO USE BOTH THE FOOT PEDAL AND THE SAMPLE BUTTON ON THE HAND PIECE TO RESET THE NEEDLE AND CHANGE TO MARKER POSITION BUT WERE UNSUCCESSFUL. WE WERE ABLE TO OBTAIN THE SAMPLES NEEDED, BUT THE MACHINE ALSO SAMPLED TWO POSITIONS THAT WE DID NOT INTEND TO SAMPLE. THE NEEDLE AND UNIT STOPPED RESPONDING AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596939 ↗
• MalfunctionJul 17, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE SYSTEM TOOK FURTHER SAMPLES WITHOUT PRESSING ANY SAMPLE BUTTONS ON EITHER FOOT PEDAL OR DRIVER. IT WAS FURTHER REPORTED THE DEVICE CONTINUED SAMPLING WHEN THE STOP PEDAL WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19758448 ↗
• MalfunctionMay 3, 2024Application Program Problem; Illegible Information; Application Program Problem; Illegible Information

  IT WAS REPORTED THAT DURING A STEREO PROCEDURE, THE DRIVER'S PROBE WOULD NOT CLOSE. THE PROBE WAS REPLACED WITH A NEW NEEDLE. THE DRIVER WAS ABLE TO CALIBRATE WITH A NEW PROBE AND SAMPLES WERE OBTAINED. HOWEVER, THE RINSE BUTTON ON THE SYSTEM'S TOUCHSCREEN WAS NOT APPEARING ON THE SCREEN. TRIED TO RESTART THE SYSTEM, BUT IT DID NOT RESOLVE THE TOUCHSCREEN FOR THE RINSE BUTTON ISSUE. ADDITIONALLY, IT WAS ALSO REPORTED THE SN ON THE DEVICE'S LABEL IS NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244395 ↗
• MalfunctionApr 9, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DRIVER INITIALLY DISPLAYED AN ERROR CODE. IT WAS FURTHER REPORTED THAT THE DRIVER STARTED TO SAMPLE ON ITS OWN AND STOPPED AFTER A WHILE BY IT'S SELF. REPORTEDLY, THE MACHINE WAS RESTARTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068972 ↗
• MalfunctionMar 4, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE TRYING TO DEPLOY THE MARKER, THE SYSTEM TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR SYSTEM, DRIVER OR FOOT PEDAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483387 ↗
• MalfunctionAug 25, 2022Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY TOOK SAMPLES FROM THE WRONG QUADRANT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291369 ↗
• MalfunctionOct 17, 2019Unintended Movement; Unintended Movement

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FSENCOR01 ENCOR ALLEGEDLY EXPERIENCED UNINTENDED MOVEMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT AGE, GENDER, AND WEIGHT WAS NO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203204 ↗
• MalfunctionApr 17, 2019Failure to Calibrate; Unintended Movement; Failure to Calibrate; Unintended Movement

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL FSENCOR01 BIOPSY INSTRUMENT ALLEGEDLY FAILED TO CALIBRATE SEVERAL TIMES AND ALLEGEDLY RAN THROUGH A SAMPLE CYCLE REPEATEDLY WITHOUT BEING ACTIVATED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVED PATIENT. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8525312 ↗
• MalfunctionMar 2, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE FOOT PEDAL ALLEGEDLY STOPPED WORKING THROUGHOUT THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE SCREEN FROZE AND THE SELECTIONS WERE NONRESPONSIVE. REPORTEDLY, THE SYSTEM WAS ABLE TO RESTART AND THE PROCEDURE WAS COMPLETED WITHOUT THE FOOT PEDAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7311667 ↗